Pilocarpine Hydrochloride
These highlights do not include all the information needed to use PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION. PILOCARPINE hydrochloride ophthalmic solution Initial U.S. Approval: 1974
Approved
Approval ID
0b138939-7472-449f-b491-ae923924b8b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2020
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pilocarpine Hydrochloride
PRODUCT DETAILS
NDC Product Code60219-1747
Application NumberANDA214193
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateSeptember 22, 2020
Generic NamePilocarpine Hydrochloride
INGREDIENTS (8)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Pilocarpine Hydrochloride
PRODUCT DETAILS
NDC Product Code60219-1746
Application NumberANDA214193
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateSeptember 22, 2020
Generic NamePilocarpine Hydrochloride
INGREDIENTS (8)
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Pilocarpine Hydrochloride
PRODUCT DETAILS
NDC Product Code60219-1745
Application NumberANDA214193
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateSeptember 22, 2020
Generic NamePilocarpine Hydrochloride
INGREDIENTS (9)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT